Duns Number:227530649
Device Description: A Transferrin test system is a device intended for the quantitative in vitro determination A Transferrin test system is a device intended for the quantitative in vitro determination of transferrin concentration in serum.
Catalog Number
TF3831
Brand Name
TF
Version/Model Number
TF3831
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K002585
Product Code
DDG
Product Code Name
Transferrin, Antigen, Antiserum, Control
Public Device Record Key
24bc00ee-3b33-4681-a3d9-e9300ba1be77
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |